Roche pushes to kick-start lung therapy Esbriet after big writedown

ZURICH (Reuters) - Roche has won U.S. breakthrough therapy status for Esbriet for interstitial lung disease (uILD), the company said on Tuesday, as it aims to lift disappointing revenue by boosting the number of conditions for which it can be used.

Esbriet, approved in 2014, is used to treat adults with lung-scarring idiopathic pulmonary fibrosis. The new designation, aimed at speeding up a U.S. Food and Drug Administration review, would broaden its label to uILD, a catch-all term for 200-plus lung-damaging disorders.


Roche acquired Esbriet six years ago with its $8.3 billion Intermune acquisition, but the Basel-based drugmaker has since written down Intermune’s value by billions as Esbriet’s $1.1 billion in annual sales have fallen short of initial expectations.

With some Esbriet patent protections scheduled to expire as early as 2021, Roche is also seeking to protect the pulmonary drug through legal action.

It has an ongoing patent lawsuit against about a dozen generics companies including Novartis’ Sandoz unit and Teva Pharmaceutical Industries, aiming to block copycat versions of Esbriet, whose generic name is pirfenidone.

MARCH 3, 2020

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